A survey on the provision of package inserts in pediatric oral formulations by pharmaceutical manufacturers in Nigeria

OBJECTIVES: The purpose of this study was to obtain data and understand how pharmaceuticals manufacturers care for safety and efficacy of the products distributed for consumption in Nigeria. The study was based on a survey of wholesale pharmacies that distribute pharmaceuticals for manufacturers. The study was carried out in Jos city, a central point in the north-central Nigeria. MATERIALS AND METHODS: Samples of pediatric formulations in pharmacies were obtained based on the product and the manufacturer. The packages were inspected for packing information leaflet and measuring devices. In addition, the manufacturing date, expiry date, storage conditions, product registration status, and the address of the manufacturer were also noted. Simple statistic was used to analyze the data. RESULTS: One hundred and twenty seven oral liquid formulations from 31 manufacturers were anayzed. The results showed that leaflet and measuring device as well as statement on storage conditions were available in 88 (69.3%), 98 (77.2%), and 114 (89.8%), respectively, in the samples studied. All products had registration numbers, suggesting that the products were authorized for distribution; this implies that some manufacturers deliberately distribute their products in forms other than the approved form. CONCLUSIONS: Manufacturers of pharmaceutical products need to be more committed to the safety and efficacy of their products at all times. Regulatory agency should increase surveillance to ensure that manufacturers consistently provide in their final packages what was declared and approved for registration.